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Review

Considerations for single- versus multiple-drug pharmacotherapy in the management of painful diabetic neuropathy

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Pages 2267-2280 | Received 12 Oct 2020, Accepted 24 Mar 2021, Published online: 05 Apr 2021

References

  • Pafili K, Papanas N, Ziegler D. Neuropathy in diabetes: “one cannot begin it too soon”. Angiology. 2018;69(9):752–754.
  • Papanas N, Vinik AI, Ziegler D. Neuropathy in prediabetes: does the clock start ticking early? Nat Rev Endocrinol. 2011;7(11):682–690.
  • Bönhof GJ, Herder C, Strom A, et al. Emerging biomarkers, tools, and treatments for diabetic polyneuropathy. Endocr Rev. 2019;40:153–192.
  • Vas PRJ, Pafili K, Papanas N. Exercise to improve diabetic peripheral neuropathy: an additional option? Neurophysiol Clin. 2018;48(4):191–193.
  • Pafili K, Papanas N. Letter to the editor regarding: diabetic peripheral neuropathy as a predictor of asymptomatic myocardial ischemia in type 2 diabetes mellitus: a cross-sectional study. Adv Ther. 2016;33(10):1848–1852.
  • Ziegler D. Painful diabetic neuropathy: treatment and future aspects. Diabetes Metab Res Rev. 2008;24(Suppl 1):S52–S57.
  • Vas PRJ, Papanas N. Depression and diabetic peripheral neuropathy: birds of a feather, but when do they flock together? Exp Clin Endocrinol Diabetes. 2020;128(5):347–349.
  • Papanas N, Ziegler D. Emerging drugs for diabetic peripheral neuropathy and neuropathic pain. Expert Opin Emerg Drugs. 2016;21(4):393–407.
  • Gilron I, Jensen TS, Dickenson AH. Combination pharmacotherapy for management of chronic pain: from bench to bedside. Lancet Neurol. 2013;12(11):1084–1095.
  • Kuo KL, Brixner D, Lipman AG, et al. Single versus multiple-drug pharmacotherapy in the management of diabetic painful neuropathy. J Pain Palliat Care Pharmacother. 2016;30(3):184–194.
  • Bril V, England J, Franklin GM, et al. Evidence-based guideline: treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology. 2011;76(20):1758–1765. .
  • Attal N, Cruccu G, Baron R, et al. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. Eur J Neurol. 2010;17(9):1113–e88.
  • Tesfaye S, Vileikyte L, Rayman G, et al. Painful diabetic peripheral neuropathy: consensus recommendations on diagnosis, assessment and management. Diabetes Metab Res Rev. 2011;27(7):629–638.
  • Finnerup NB, Attal N, Haroutounian S, et al. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015;14(2):162–173.
  • Moore RA, Derry S, Aldington D, et al. Amitriptyline for neuropathic pain in adults. Cochrane Database Syst Rev. 2015;2015:CD008242.
  • Onghena P, Van Houdenhove B. Antidepressant-induced analgesia in chronic non-malignant pain: a meta-analysis of 39 placebo-controlled studies. Pain. 1992;49(2):205–219.
  • Boyle J, Eriksson MEV, Gribble L, et al. Randomized, placebo-controlled comparison of amitriptyline, duloxetine, and pregabalin in patients with chronic diabetic peripheral neuropathic pain: impact on pain, polysomnographic sleep, daytime functioning, and quality of life. Diabetes Care. 2012;35(12):2451–2458.
  • Biesbroeck R, Bril V, Hollander P, et al. A double-blind comparison of topical capsaicin and oral amitriptyline in painful diabetic neuropathy. Adv Ther. 1995;12(2):111–120.
  • Jose VM, Bhansali A, Hota D, et al. Randomized double-blind study comparing the efficacy and safety of lamotrigine and amitriptyline in painful diabetic neuropathy. Diabet Med. 2007;24(4):377–383.
  • Max MB, Lynch SA, Muir J, et al. Effects of desipramine, amitriptyline, and fluoxetine on pain in diabetic neuropathy. N Engl J Med. 1992;326(19):1250–1256.
  • Gallagher HC, Gallagher RM, Butler M, et al. Venlafaxine for neuropathic pain in adults. Cochrane Database Syst Rev. 2015;2015:CD011091.
  • Bolden-Watson C, Richelson E. Blockade by newly-developed antidepressants of biogenic amine uptake into rat brain synaptosomes. Life Sci. 1993;52(12):1023–1029.
  • Muth EA, Haskins JT, Moyer JA, et al. Antidepressant biochemical profile of the novel bicyclic compound Wy-45,030, an ethyl cyclohexanol derivative. Biochem Pharmacol. 1986;35(24):4493–4497.
  • Schreiber S, Backer MM, Pick CG. The antinociceptive effect of venlafaxine in mice is mediated through opioid and adrenergic mechanisms. Neurosci Lett. 1999;273(2):85–88.
  • Rowbotham MC, Goli V, Kunz NR, et al. Venlafaxine extended release in the treatment of painful diabetic neuropathy: a double-blind, placebo-controlled study. Pain. 2004;110(3):697–706.
  • Kadiroglu AK, Sit D, Kayabasi H, et al. The effect of venlafaxine HCl on painful peripheral diabetic neuropathy in patients with type 2 diabetes mellitus. J Diabetes Complications. 2008;22(4):241–245.
  • Aiyer R, Barkin RL, Bhatia A. Treatment of neuropathic pain with venlafaxine: a systematic review. Pain Med. 2017;18(10):1999–2012.
  • Razazian N, Baziyar M, Moradian N, et al. Evaluation of the efficacy and safety of pregabalin, venlafaxine, and carbamazepine in patients with painful diabetic peripheral neuropathy. A randomized, double-blind trial. Neurosciences (Riyadh). 2014;19(3):192–198.
  • Sultan A, Gaskell H, Derry S, et al. Duloxetine for painful diabetic neuropathy and fibromyalgia pain: systematic review of randomised trials. BMC Neurol. 2008;8(1):29.
  • Ziegler D. Duloxetine, a new therapeutic option for diabetic peripheral neuropathic pain. Dtsch Med Wochenschr. 2006;131(Suppl S 8):S284–S288.
  • Raskin J, Pritchett YL, Wang F, et al. A double-blind, randomized multicenter trial comparing duloxetine with placebo in the management of diabetic peripheral neuropathic pain. Pain Med. 2005;6(5):346–356.
  • Goldstein DJ, Lu Y, Detke MJ, et al. Duloxetine vs. placebo in patients with painful diabetic neuropathy. Pain. 2005;116(1):109–118.
  • Wernicke JF, Pritchett YL, D’Souza DN, et al. A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain. Neurology. 2006;67(8):1411–1420.
  • Kajdasz DK, Iyengar S, Desaiah D, et al. Duloxetine for the management of diabetic peripheral neuropathic pain: evidence-based findings from post hoc analysis of three multicenter, randomized, double-blind, placebo-controlled, parallel-group studies. Clin Ther. 2007;29(11):2536–2546.
  • Boyle Y, Fernando D, Kurz H, et al. The effect of a combination of gabapentin and donepezil in an experimental pain model in healthy volunteers: results of a randomized controlled trial. Pain. 2014;155(12):2510–2516.
  • Verma V, Singh N, Singh Jaggi A. Pregabalin in neuropathic pain: evidences and possible mechanisms. Curr Neuropharmacol. 2014;12(1):44–56.
  • De Guglielmo G, Cippitelli A, Somaini L, et al. Pregabalin reduces cocaine self-administration and relapse to cocaine seeking in the rat. Addict Biol. 2013;18(4):644–653.
  • Schjerning O, Rosenzweig M, Pottegård A, et al. Abuse potential of pregabalin: a systematic review. CNS Drugs. 2016;30(1):9–25.
  • Evo KE, Morrison MD, Saklad SR. Abuse and misuse of pregabalin and gabapentin. Drugs. 2017;77(4):403–426.
  • Rauck R, Makumi CW, Schwartz S, et al. A randomized, controlled trial of gabapentin enacarbil in subjects with neuropathic pain associated with diabetic peripheral neuropathy. Pain Pract. 2013;13(6):485–496.
  • Smith T, DiBernardo A, Shi Y, et al. Efficacy and safety of carisbamate in patients with diabetic neuropathy or postherpetic neuralgia: results from 3 randomized, double-blind placebo-controlled trials. Pain Pract. 2014;14(4):332–342.
  • Vinik A, Rosenstock J, Sharma U, et al. Efficacy and safety of mirogabalin (DS-5565) for the treatment of diabetic peripheral neuropathic pain: a randomized, double-blind, placebo- and active comparator-controlled, adaptive proof-of-concept phase 2 study. Diabetes Care. 2014;37(12):3253–3261.
  • Ziegler D, Duan WR, An G, et al. A randomized double-blind, placebo-, and active-controlled study of T-type calcium channel blocker ABT-639 in patients with diabetic peripheral neuropathic pain. Pain. 2015;156(10):2013–2020.
  • Gonzalez-Duarte A, Lem M, Díaz-Díaz E, et al. The efficacy of pregabalin in the treatment of prediabetic neuropathic pain. Clin J Pain. 2016;32(11):927–932.
  • Derry S, Bell RF, Straube S, et al. Pregabalin for neuropathic pain in adults. Cochrane Database Syst Rev. 2019;1:CD007076.
  • Bansal D, Bhansali A, Hota D, et al. Amitriptyline vs. pregabalin in painful diabetic neuropathy: a randomized double blind clinical trial. Diabet Med. 2009;26(10):1019–1026.
  • Enomoto H, Yasuda H, Nishiyori A, et al. Duloxetine in patients with diabetic peripheral neuropathic pain in Japan: a randomized, doubleblind, noninferiority comparative study with pregabalin. J Pain Res. 2018;11:1857–1868.
  • Chang CY, Challa CK, Shah J, et al. Gabapentin in acute postoperative pain management. Biomed Res Int. 2014;2014:631756.
  • Eroglu C, Allen NJ, Susman MW, et al. Gabapentin receptor alpha2delta-1 is a neuronal thrombospondin receptor responsible for excitatory CNS synaptogenesis. Cell. 2009;139(2):380–392.
  • Sang CN, Sathyanarayana R, Sweeney M. DM-1796 Study Investigators. Gastroretentive gabapentin (G-GR) formulation reduces intensity of pain associated with postherpetic neuralgia (PHN). Clin J Pain. 2013;29(4):281–288.
  • Backonja MM, Canafax DM, Cundy KC. Efficacy of gabapentin enacarbil vs placebo in patients with postherpetic neuralgia and a pharmacokinetic comparison with oral gabapentin. Pain Med. 2011;12(7):1098–1108.
  • Quintero GC. Review about gabapentin misuse, interactions, contraindications and side effects. J Exp Pharmacol. 2017;9:13–21.
  • Backonja M, Beydoun A, Edwards KR, et al. Gabapentin for the Symptomatic Treatment of Painful Neuropathy in Patients With Diabetes Mellitus. A Randomized Controlled Trial. JAMA. 1998;280(21):1831–1836.
  • Gorson KC, Schott C, Herman R, et al. Gabapentin in the treatment of painful diabetic neuropathy: a placebo controlled, double blind, crossover trial. J Neurol Neurosurg Psychiatry. 1999;66(2):251–252.
  • Perez HE, Sanchez GF. Gabapentin therapy for diabetic neuropathic pain. Am J Med. 2000;108(8):689.
  • Wiffen PJ, Derry S, Bell RF, et al. Gabapentin for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2017;6:CD007938.
  • Morello CM, Leckband SG, Stoner CP, et al. Randomized double-blind study comparing the efficacy of gabapentin with amitriptyline on diabetic peripheral neuropathy pain. Arch Intern Med. 1999;159(16):1931–1937.
  • Sandercock D, Cramer M, Wu J, et al. Gabapentin extended release for the treatment of painful diabetic peripheral neuropathy: efficacy and tolerability in a double-blind, randomized, controlled clinical trial. Diabetes Care. 2009;32(2):e20.
  • Vinik AI, Casellini CM. Guidelines in the management of diabetic nerve pain: clinical utility of pregabalin. Diabetes Metab Syndr Obes. 2013;6:57–78.
  • Harati Y, Gooch C, Swenson M, et al. Double-blind randomized trial of tramadol for the treatment of the pain of diabetic neuropathy. Neurology. 1998;50(6):1842–1846.
  • Gilron I, Bailey JM, Tu D, et al. Morphine, gabapentin, or their combination for neuropathic pain. N Engl J Med. 2005;352(13):1324–1334.
  • Gimbel JS, Richards P, Portenoy RK. Controlled-release oxycodone for pain in diabetic neuropathy: a randomized controlled trial. Neurology. 2003;60(6):927–934.
  • Watson CP, Moulin D, Watt-Watson J, et al. Controlled-release oxycodone relieves neuropathic pain: a randomized controlled trial in painful diabetic neuropathy. Pain. 2003;105(1):71–78.
  • Schwartz S, Etropolski M, Shapiro DY, et al. Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized-withdrawal, placebo-controlled trial. Curr Med Res Opin. 2011;27(1):151–162.
  • Dworkin RH, O’Connor AB, Audette J, et al. Recommendations for the pharmacological management of neuropathic pain: an overview and literature update. Mayo Clin Proc. 2010;85(3):S3–14.
  • Blom S. Trigeminal neuralgia: its treatment with a new anticonvulsant drug (G-32883). Lancet. 1962;279(7234):839–840.
  • Gutierrez-Alvarez AM, Beltran-Rodriguez J, Moreno CB. Antiepileptic drugs in treatment of pain caused by diabetic neuropathy. J Pain Symptom Manage. 2007;34(2):201–208.
  • Jarvis B, Coukell AJ. Mexiletine: a review of its therapeutic use in painful diabetic neuropathy. Drugs. 1998;56(4):691–707.
  • Agrawal RP, Choudhary R, Sharma P, et al. Glyceryl trinitrate spray in the management of painful diabetic neuropathy: a randomized double blind placebo controlled cross-over study. Diabetes Res Clin Pract. 2007;77(2):161–167.
  • Flores MP, Castro AP, Nascimento Jdos S. Topical analgesics. Rev Bras Anestesiol. 2012;62(2):244–252.
  • Baron R, Mayoral V, Leijon G, et al. Efficacy and safety of combination therapy with 5% lidocaine medicated plaster and pregabalin in post-herpetic neuralgia and diabetic polyneuropathy. Curr Med Res Opin. 2009;25(7):1677–1687.
  • Ho KY, Huh BK, White WD, et al. Topical amitriptyline versus lidocaine in the treatment of neuropathic pain. Clin J Pain. 2008;24(1):51–55.
  • Lynch ME, Clark AJ, Sawynok J, et al. Topical 2% amitriptyline and 1% ketamine in neuropathic pain syndromes: a randomized, double-blind, placebo-controlled trial. Anesthesiology. 2005;103(1):140–146.
  • Estebe JP, Myers RR. Amitriptyline neurotoxicity: dose-related pathology after topical application to rat sciatic nerve. Anesthesiology. 2004;100(6):1519–1525.
  • Tandan R, Lewis GA, Krusinski PB, et al. Topical capsaicin in painful diabetic neuropathy. Controlled study with long-term follow-up. Diabetes Care. 1992;15(1):8–14.
  • Simpson DM, Robinson-Papp J, Van J, et al. Capsaicin 8% patch in painful diabetic peripheral neuropathy: a randomized, double-blind, placebo-controlled study. J Pain. 2017;18(1):42–53.
  • Vinik AI, Perrot S, Vinik EJ, et al., Capsaicin 8% patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy: a randomised, 52-week, open-label, safety study. BMC Neurol. 16(1): 251. 2016.
  • Boulton AJM, Kempler P, Ametov A, et al. Whither pathogenetic treatments for diabetic polyneuropathy? Diabetes Metab Res Rev. 2013;29:327–333.
  • Simpson DA. Gabapentin and venlafaxine for the treatment of painful diabetic neuropathy. J Clin Neuromuscul Dis. 2001;3(2):53–62.
  • Tanenberg RJ, Irving GA, Risser RC, et al. Duloxetine, pregabalin, and duloxetine plus gabapentin for diabetic peripheral neuropathic pain management in patients with inadequate pain response to gabapentin: an open-label, randomized, noninferiority comparison. Mayo Clin Proc. 2011;86(7):615–626.
  • Irving G, Tanenberg RJ, Raskin J, et al. Comparative safety and tolerability of duloxetine vs. pregabalin vs. duloxetine plus gabapentin in patients with diabetic peripheral neuropathic pain. Int J Clin Pract. 2014;68(9):1130–1140.
  • Gilron I, Bailey JM, Tu D, et al. Nortriptyline and gabapentin, alone and in combination for neuropathic pain: a double-blind, randomised controlled crossover trial. Lancet. 2009;374:1252–1261.
  • Hanna M, O’Brien C, Wilson MC. Prolonged-release oxycodone enhances the effects of existing gabapentin therapy in painful diabetic neuropathy patients. Eur J Pain. 2008;12(6):804–813.
  • Zin CS, Nissen LM, O’Callaghan JP, et al. A randomized, controlled trial of oxycodone versus placebo in patients with postherpetic neuralgia and painful diabetic neuropathy treated with pregabalin. J Pain. 2010;11(5):462–471.
  • Gatti A, Sabato AF, Occhioni R, et al. Controlled-release oxycodone and pregabalin in the treatment of neuropathic pain: results of a multicenter Italian study. Eur Neurol. 2009;61(3):129–137.
  • Mimenza Alvarado A, Navarro SA. Clinical trial assessing the efficacy of gabapentin plus B Complex (B1/B12) versus Pregabalin for treating painful diabetic neuropathy. J Diabetes Res. 2016;2016:4078695.
  • Tesfaye S, Wilhelm S, Lledo A, et al., Duloxetine and pregabalin: high-dose monotherapy or their combination? The “COMBO-DN study”–a multinational, randomized, double-blind, parallel-group study in patients with diabetic peripheral neuropathic pain. Pain. 154(12): 2616–2625. 2013.
  • Bouhassira D, Wilhelm S, Schacht A, et al. Neuropathic pain phenotyping as a predictor of treatment response in painful diabetic neuropathy: data from the randomized, double-blind, COMBO-DN study. Pain. 2014;155(10):2171–2179.
  • Agrawal RP, Goswami J, Jain S, et al. Management of diabetic neuropathy by sodium valproate and glyceryl trinitrate spray: a prospective double-blind randomized placebo-controlled study. Diabetes Res Clin Pract. 2009;83(3):371–378.
  • Lynch ME, Clark AJ, Sawynok J. A pilot study examining topical amitriptyline, ketamine, and a combination of both in the treatment of neuropathic pain. Clin J Pain. 2003;19(5):323–328.
  • Gomez-Perez FJ, Rull JA, Dies H, et al. Nortriptyline and fluphenazine in the symptomatic treatment of diabetic neuropathy. A double-blind cross-over study. Pain. 1985;23:395–400.
  • Gomez-Perez FJ, Choza R, Ríos JM, et al. Nortriptyline-fluphenazine vs. carbamazepine in the symptomatic treatment of diabetic neuropathy. Arch Med Res. 1996;27(4):525–529.
  • Ko SH, Kwon H-S, Yu J-M, et al. Comparison of the efficacy and safety of tramadol/acetaminophen combination therapy and gabapentin in the treatment of painful diabetic neuropathy. Diabet Med. 2010;27(9):1033–1040.
  • Freeman R, Raskin P, Hewitt DJ, et al. Randomized study of tramadol/acetaminophen versus placebo in painful diabetic peripheral neuropathy. Curr Med Res Opin. 2007;23(1):147–161.
  • Battla H, Silverblatt CW. Clinical trial of amitriptyline and fluphenazine in diabetic peripheral neuropathy. South Med J. 1981;74(4):417–418.
  • Cegielska-Perun K, Bujalska-Zadrozny M, Makulska-Nowak HE. Modification of morphine analgesia by venlafaxine in diabetic neuropathic pain model. Pharmacol Rep. 2012;64(5):1267–1275.
  • Tripathi CD, Mehta AK, Yadav AM. Drug combinations in diabetic neuropathic pain: an experimental validation. J Basic Clin Physiol Pharmacol. 2016;27(6):617–624.
  • Miranda HF, Sierralta F, Aranda N, et al. Synergism between gabapentin-tramadol in experimental diabetic neuropathic pain. Fundam Clin Pharmacol. 2018;32(6):581–588.
  • Miranda HF, Poblete P, Sierralta F, et al. Interleukin-1beta in synergism gabapentin with tramadol in murine model of diabetic neuropathy. Inflammopharmacology. 2019;27(1):151–155.
  • Sadeghiyan Galeshkalami N, Abdollahi M, Najafi R, et al. Alpha-lipoic acid and coenzyme Q10 combination ameliorates experimental diabetic neuropathy by modulating oxidative stress and apoptosis. Life Sci. 2019;216:101–110.
  • Consoli A, Czupryniak L, Duarte R, et al. Positioning sulphonylureas in a modern treatment algorithm for patients with type 2 diabetes: expert opinion from a European consensus panel. Diabetes Obes Metab 2020 June 1 [Online ahead of print].
  • Sachinidis A, Nikolic D, Stoian AP, et al. Cardiovascular outcomes trials with incretin-based medications: a critical review of data available on GLP-1 receptor agonists and DPP-4 inhibitors. Metabolism. 2020;111:154343.
  • Ziegler D, Papanas N, Schnell O, et al. Current concepts in the management of diabetic polyneuropathy. J Diabetes Investig 2020Sep 12 [Online ahead of print].
  • Ardeleanu V, Toma A, Pafili K, et al. Current pharmacological treatment of painful diabetic neuropathy: a narrative review. Medicina (Kaunas). 2020;56(1):1.
  • Chen W, Yang GY, Liu B, et al. Manual acupuncture for treatment of diabetic peripheral neuropathy: a systematic review of randomized controlled trials. PLoS One. 2013;8(9):e73764.
  • Thakral G, Kim PJ, LaFontaine J, et al. Electrical stimulation as an adjunctive treatment of painful and sensory diabetic neuropathy. J Diabetes Sci Technol. 2013;7(5):1202–1209.

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